ClinicalTrials.gg
CompletedNCT03314142Updated Oct 20, 2017

Effects of Bran Size on Glycemic Responses

An interventional study of Glucose as reference food and White bread as reference food in Potential Abnormality of Glucose Tolerance and Appetitive Behavior, sponsored by Agricultural University of Athens. Completed at 1 site in Greece. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-20.

Sponsored by Agricultural University of Athens · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study investigated the effects of bran's particle size on glycemic responses

Read the detailed description

This study aimed at 1. to determine the GI and GL of three breads and 2. to investigate the effects of bran's particle size on postprandial glycemic response in healthy subjects.

02

Conditions studied

  • Potential Abnormality of Glucose Tolerance
  • Appetitive Behavior

Browse trials for

Keywords

  • blood glucose
  • bran particle size
  • glucemic index
03

In context

Appetitive Behavior

96 studies on the registry are indexed under Appetitive Behavior; 6 are open to participants now.

This study's enrollment of 10 is below the median of 26 across 87 interventional studies indexed under Appetitive Behavior.

Browse Appetitive Behavior studies →

Lead sponsor

Agricultural University of Athens is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy, non-smoking, non-diabetic men and women, individuals with normal (BMI; between 18.5 and 24.9 kg/m2)

Exclusion criteria

Exclusion Criteria:

  • severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
  • gastrointestinal disorders
  • pregnancy
  • lactation
  • competitive sports
  • alcohol or drug dependency
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Glucose as reference food

    Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

    Other: Glucose as reference food · Other: White bread as reference food · Other: Bread enriched with coarse wheat bran · Other: Bread enriched with fine wheat bran · Other: Bread enriched with fine wheat bran and carob seed flour

  • Experimental
    White bread as reference food

    Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

    Other: Glucose as reference food · Other: White bread as reference food · Other: Bread enriched with coarse wheat bran · Other: Bread enriched with fine wheat bran · Other: Bread enriched with fine wheat bran and carob seed flour

  • Experimental
    Bread enriched with coarse wheat bran

    Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

    Other: Glucose as reference food · Other: White bread as reference food · Other: Bread enriched with coarse wheat bran · Other: Bread enriched with fine wheat bran · Other: Bread enriched with fine wheat bran and carob seed flour

  • Experimental
    Bread enriched with fine wheat bran

    Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

    Other: Glucose as reference food · Other: White bread as reference food · Other: Bread enriched with coarse wheat bran · Other: Bread enriched with fine wheat bran · Other: Bread enriched with fine wheat bran and carob seed flour

  • Experimental
    Bread enriched with fine wheat and carob

    Ten healthy, normal weight subjects (male: 7, female: 3) after 10-14 hr fast, consumed 50g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 50g available carbohydrates from bread enriched with coarse wheat bran (CB), bread enriched with fine wheat bran (obtained by milling the coarse bran) (FB) and the FB in which 10% of the flour was substituted with carob seed flour (CSFB), tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

    Other: Glucose as reference food · Other: White bread as reference food · Other: Bread enriched with coarse wheat bran · Other: Bread enriched with fine wheat bran · Other: Bread enriched with fine wheat bran and carob seed flour

Interventions

  • OtherGlucose as reference food

    Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

  • OtherWhite bread as reference food

    Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

  • OtherBread enriched with coarse wheat bran

    Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

  • OtherBread enriched with fine wheat bran

    Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

  • OtherBread enriched with fine wheat bran and carob seed flour

    Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

06

What researchers measure

Primary outcomes

  1. Capillary blood glucose responses

    Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test.

    Time frame: 2 hours

Secondary outcomes

  1. Subjective appetite ratings

    Useful change in subjective appetite using visual analogue scales (VAS, 100 mm, given in the form of booklet, one scale per page) before and 2hr after consumption of four different bread types.

    Time frame: 2 hours

07

Study locations

1 site
  • Agricultural University of Athens
    Athens, 11855, Greece
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Jul 2017, 4 months.

Of 75 non-industry interventional studies with no phase under Appetitive Behavior, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 4 months is below that.

Counting every sponsor, half of 76 studies reached it within 7 months; a quarter within 3 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2017
First posted
Oct 19, 2017
StartActual
Mar 30, 2017
Primary completionActual
Jul 30, 2017
CompletionActual
Sep 30, 2017
Last update
Oct 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03314142
Lead sponsor
Agricultural University of Athens
Responsible party
Aimilia Papakonstantinou (Lecturer in Nutrition and Metabolism, Agricultural University of Athens) — Principal investigator
First posted
Oct 19, 2017
Start date
Mar 30, 2017
Primary completion
Jul 30, 2017
Completion
Sep 30, 2017
Last update
Oct 20, 2017

Study contacts

Emilia Papakonstantinou, PhD
principal investigator · Agricultural University of Athens

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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